In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Pfizer released positive top line results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide). 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Cancer start-up Black Diamond Therapeutics has announced a significant restructuring as part of its plan to focus resources on its lead drug, BDTX-1535. 10 October 2024
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
China’s Quantum Pharmaceuticals has announced a significant licensing agreement between its biologics-focused subsidiary, Ailux Biologics, and Johnson & Johnson. 10 October 2024
Advances in gene editing, such as the FDA approval of Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) in December 2023 for the treatment of beta thalassemia and sickle cell disease, have fueled significant interest in innovative epigenetic drugs. 10 October 2024
German family-owned pharma major Boehringer Ingelheim and USA-based Circle Pharma (have entered into a research collaboration and license agreement with the shared goal to develop a first-in-class cyclin inhibitor that can halt the growth of cancer cells potentially offering hope to those living with hard-to-treat cancers. 9 October 2024
Bayer has entered into a collaboration with MOMA Therapeutics to develop a small molecule oncology program using the latter’s proprietary KNOMATIC platform. 9 October 2024
Genor Biopharma has announced plans for a significant merger with Edding Group, marking one of the first reverse takeovers involving a Hong Kong-listed biopharma company. 8 October 2024
China-headquartered clinical-stage biotech MediLink Therapeutics has announced a global clinical trial collaboration and supply agreement with US major Amgen. 8 October 2024
Germany’s Eckert & Ziegler, a specialist in radioisotopes for medical, scientific and industrial applications, has announced a global clinical supply agreement with GlyTherix, an Australian targeted radiotherapy firm specializing in developing antibody radiopharmaceuticals for solid tumors. 8 October 2024
US clinical-stage biotech OnKure Therapeutics has announced the completion of its previously announced merger with Reneo Pharmaceuticals. 8 October 2024
Daejeon-based Orum Therapeutics, a specialist in degrader-antibody conjugates (DAC), has filed for an initial public offering (IPO) on South Korea's Kosdaq market. 7 October 2024
Mosaic Therapeutics, a UK-based oncology therapeutics company dedicated to resolving cancer’s complexity to power new combination therapies for patients, has announced the appointment of Barry Davies as chief scientific officer. 7 October 2024
EMD Serono, a US subsidiary of Germany’s Merck KGaA has entered into a collaboration and license agreement with California-based biotech firm Sutro Biopharma to develop antibody drug conjugates (ADCs). 18 September 2014
Germany’s Merck KGaA says that its biopharmaceutical division - Merck Serono - is well on track with the implementation of the group’s “Fit for 2018” transformation and growth program. 18 September 2014
Declining budgets have slowed the pace of research into cancer, according to a new report from the American Association for Cancer Research (AACR). 18 September 2014
UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending UK pharma giant GlaxoSmithKline’s Tafinlar (dabrafenib) for the treatment of melanoma which has spread or can’t be completely removed by surgery and tests positive for the BRAF V600 mutation. 18 September 2014
US biotech major Gilead Sciences has announced disappointing results from a Phase II study evaluating simtuzumab, an investigational inhibitor of lysyl oxidase-like-2 (LOXL2), in combination with gemcitabine for patients with previously untreated advanced pancreatic cancer. 17 September 2014
Pancreatic cancer drug Abraxane (paclitaxel protein-bound particles for injectable suspension), from US biotech company Celgene, will be listed on the Australian Pharmaceutical Benefits Scheme (PBS) effective from November 1. 17 September 2014
Although many new products have been launched since 2010 to treat metastatic castration-resistant prostate cancer, there is still ample opportunity for drug developers to bring new therapies to market, says an analyst from research and consulting firm GlobalData. 17 September 2014
Privately-held San Diego, USA-based biotech firm Denovo Biopharma has acquired enzastaurin, a late-stage oncology drug from pharma major Eli Lilly, gaining all rights to develop, manufacture and commercialize enzastaurin globally, including transfer of all intellectual property and other rights, data, and information. 17 September 2014
The UK’s Department of Health announced that DCVax-L, the dendritic cell-based vaccine from US company Northwest Biotherapeutics, will be the first drug to be awarded Promising Innovative Medicine (PIM) status, covering all malignant gliomas, including glioblastoma multiforme. 17 September 2014
The charity Cancer Research UK and its commercialization arm Cancer Research Technology (CRT), have reached an agreement with US biotech firm Asterias Biotherapeutics, a subsidiary of BioTime, to take forward Asterias’ novel immunotherapy treatment AST-VAC2 into clinical trials in subjects with non-small cell lung cancer. 15 September 2014
The monoclonal antibodies market for gastric and esophageal cancer is expected to double by 2019, according to a report by market research firm Reportstack. 15 September 2014
US pharma major Eli Lilly says that the RAISE trial, a Phase III study of ramucirumab (already marketed as Cyramza) in combination with chemotherapy in patients with metastatic colorectal cancer (mCRC), met its primary endpoint of overall survival. 14 September 2014
Merck Serono, the biotech unit of Germany’s Merck KGaA, is to discontinue the clinical development program of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide (L-BLP25) as a monotherapy for stage III non-small cell lung cancer (NSCLC). 12 September 2014
Clinical stage oncology drug development company MabVax Therapeutics has entered agreements with Memorial Sloan Kettering and Juno Therapeutics for the development of new therapeutics using antibody-targeting sequences derived from the fully-human antibodies discovered using MabVax’ antibody discovery platform. 11 September 2014
The US Food and Drug Administration has approved a new indication for the use of Japanese drug major Astellas Pharma and Medivation’s Xtandi (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC). 11 September 2014
Biotech companies Seattle Genetics of the USA and Denmark’s Genmab have entered into an additional antibody-drug conjugate collaboration. The news pushed Seattle’s shares up 2.3% to $41.04, in mid-morning US trading, while Genmab dipped 0.7% to 224.60 Danish kroner mid-afternoon n the Copenhagen exchange. 10 September 2014
The global non-small cell lung cancer treatment market value will increase from $5.1 billion in 2013 to slightly over $7.9 billion by 2020, expanding at a compound annual growth rate of 6.6%. 9 September 2014
UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has published new draft guidance which recommends that US biotech major Celgene’s Abraxane (nab-paclitaxel) taken with gemcitabine should not be funded by the National Health Service. 9 September 2014
US drug major Bristol-Myers Squibb and partner Japan’s Ono Pharmaceutical have filed a law suit against pharma giant Merck & Co over Keytruda (pembrolizumab) for advanced melanoma. 8 September 2014